The pan-Canadian Pharmaceutical Alliance (pCPA) has launched its Temporary Access Process (pTAP) to facilitate early market access to new drugs that were assessed under the time-limited reimbursement recommendation (TLR) pathway at the Canada Drug and Health Technology Agency (CADTH). The pCPA has published principles and conditions for the pTAP as well as information on its negotiation process and pricing. 

Background on CADTH time-limited recommendations

CADTH conducts health technology assessments (HTAs) for provincial (except Québec), territorial, and federal publicly-funded drug plans (public plans). An HTA assesses a drug’s clinical and cost effectiveness. 

In September 2023, CADTH implemented a TLR pathway to facilitate HTA of new drugs that show early promise for treating a serious condition where there is an unmet medical need (as we reported here). Drugs qualify for the TLR pathway if, among other requirements, they have been given conditional regulatory approval under Health Canada’s Notice of Compliance with Conditions (NOC/c) policy and a phase III clinical trial is being planned and/or conducted, with the study’s finding to be reported within three years. 

In other words, a promising drug can be conditionally approved for sale (by Health Canada) and its clinical and cost effectiveness assessed using preliminary evidence (by CADTH), while the drug manufacturer collects more evidence that confirms the drug’s effectiveness. The question addressed by the pTAP is whether and how this drug will be funded – temporarily – by public plans, while the manufacturer collects the additional evidence.

pTAP principles and conditions 

In July 2023, the pCPA proposed principles and conditions for pTAP and requested feedback from stakeholders (i.e., clinicians, patient groups, industry). As we reported, the proposed principles included:

  • Participation in pTAP is required if the manufacturer participates in CADTH’s TLR pathway.
  • If public funding of a drug is not continued beyond the temporary period, the manufacturer must provide coverage for any patient started on the drug during the temporary period.

Despite specific concerns raised during the consultation, the final principles and conditions for pTAP are essentially unchanged from those proposed in 2023.

pTAP negotiation process

The pCPA has provided an overview of the pTAP negotiation process:

  • Step 1: Once a manufacturer receives the initial economic report from CADTH, the pCPA will evaluate the drug to decide whether it will pursue a negotiated agreement.
  • Step 2: If so, a structured negotiation process will be initiated, prior to the TLR recommendation from CADTH.  The pTAP negotiations will not follow the target timelines for other pCPA negotiations and will be “designed to ensure momentum, as opposed to a protracted negotiation”.
  • Step 3: If the negotiation is successful, a temporary confidential public drug plan price will be established that applies to patients who meet eligibility criteria (as set out in the TLR).
  • Step 4: The temporary agreement will be in effect until a final (long-term) agreement is negotiated, as triggered by a positive final HTA recommendation.

Any patients granted public coverage under the pTAP will continue to be covered by the public plan until:

  1. Confirmatory evidence is not submitted for HTA after three years (or a time agreed to by the pCPA);
  2. Confirmatory evidence does not show a clinical benefit after a final HTA review (including a final HTA recommendation of “do not reimburse” or a more restrictive recommendation than initially provided); or
  3. The pCPA and the manufacturer are unable to reach a final (long-term) agreement.

If any one of these events occurs, coverage of existing patients will be assumed by the manufacturer and will continue until the prescriber and patient determine the drug is no longer required.

pTAP pricing

Finally, the pCPA set out some general information on pTAP pricing. The pCPA indicated that cost-effectiveness will be “applied consistently with all products using a predetermined weighting of disease severity and incremental clinical benefit”. The pCPA also set out the following definitions:

  • Standard and specialized products. A specialized product is one that treats a “rare disease” or a “severe rare disease” and/or “[u]ses new technology to address a significant unmet need compared to existing options”. All other products are standard products.
  • Disease severity. Disease severity is “the future health lost by people living with the condition under standard of care in Canada”.